Duns Number:058614483
Device Description: Clip Applier Cartridge
Catalog Number
500-28
Brand Name
Endo Clip MultApplier
Version/Model Number
500-28
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K954435,K954435
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
7f00c5d8-6385-4b22-92c8-580191cd8791
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
August 28, 2015
Package DI Number
10884521057500
Quantity per Package
10
Contains DI Package
20884521057507
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |